12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medline Integrated Arterial Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Anti-Human Globulin Anti-C3d
FDA UDI
DIAGAST·23661562105483·Anti-Human Globulin Anti-C3d (Murine Monoclonal...
ELMED
FDA UDI
ELMED INCORPORATED·00842180107458·5 MM DIA., 45 CM INSULATED J-HOOK ELECTRODE, WI...
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QKP·September 22, 2020
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·October 6, 2020
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
FDA 510(k)
FDA Class 2
·Neurology
OSI O-BALL ABUTMENT HEAD IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
UNKNOWN DEPUY HIP LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWB·October 22, 2008
UNKNOWN SPINAL CORD STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·August 10, 2011
UNIFY QUADRA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·September 29, 2020
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021